MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NON-INVASIVE PATIENT TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9734887
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system being used during a catheter placement procedure.It was reported that there were no issues registering.However, when the surgeon was ready to place the shunt, there were communication issues with the non-invasive patient tracker (nipt).The nipt was showing as red and not listing a geometry error.Moving the emitter did not improve tracking.However, other instrumentation was able to track.The surgeon free handed the remainder of the surgery.This was an out-of-box issue with the instrument.The procedure was delayed by 10 minutes and there was no impact to patient outcome.

• Brand Name: NON-INVASIVE PATIENT TRACKER
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 12698549
• Report Number: 1723170-2021-02566
• Device Sequence Number: 19829315
• Product Code: HAW
• UDI-Device Identifier: 00643169488113
• UDI-Public: 00643169488113
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/11/2024
• Device Model Number: 9734887
• Device Catalogue Number: 9734887
• Device Lot Number: 210512D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 74